Cleared Traditional

K943394 - PROSTAT CONTROL (FDA 510(k) Clearance)

Class I Immunology device.

K943394 · Quantimetrix Corp. · Immunology device
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May 1995
Decision
313d
Days
Class 1
Risk

K943394 is an FDA 510(k) clearance for the PROSTAT CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Quantimetrix Corp. (Hawthorne, US). The FDA issued a Cleared decision on May 23, 1995 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Quantimetrix Corp. devices

Submission Details

510(k) Number K943394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1994
Decision Date May 23, 1995
Days to Decision 313 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 104d · This submission: 313d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.